S-301

Phase 1 Study Led by World-Renowned Expert Prof. Felice Petraglia to Evaluate Gynica's Non-Hormonal, Intra-Vaginal Drug Candidates In perfect timing with Endometriosis Awareness Month, the announcement of the study is one step forward for the well-being and quality of life of over 200 million women in the world FLORENCE, Italy, March 14, 2024 /PRNewswire/ -- Gynica, a clinical-stage women's health biotech startup developing a novel Endometriosis treatment, announces today the submission of a first-in-human Phase 1 trial. The global first-of-its-kind clinical study will take place at Careggi University Hospital in Florence, Italy. It will evaluate the safety, tolerability, and pharmacokinetics of the IntraVag© intra-vaginal drug delivery platform and two proprietary drug candidates, S-301 and S-302. Gynica, which was founded in 2019, set a goal to develop a solution for one of the most common but untreated diseases in the world - Endometriosis; a debilitating disease characterised by abnormal growth of uterine-like tissue outside the uterus, has a devastating impact on the lives of over 200 million women globally - around 1 in 10 of reproductive age. The physical and emotional tolls are immense, disrupting careers, relationships, and overall quality of life for these women. Despite its widespread prevalence representing an estimated $180 billion annual market according to the World Economic Forum and Mckinsey's Health Institute, Endometriosis continues to be an underserved and underfunded area lacking truly effective treatment solutions. As awareness of this condition continues rising, there is an urgent need to develop innovative therapies that can finally provide relief and restore quality of life for the hundreds of millions profoundly impacted by endometriosis worldwide. This global-first clinical study will evaluate Gynica's proprietary pharmaceutical-standard cannabinoids-based formulations intravaginally. Through these first-of-their-kind studies, the company is leveraging the promising potential of cannabinoids as therapeutic agents in women's health. The trial will be led by world-renowned Endometriosis expert Prof. Felice Petraglia, Past President and founding member of the Society for Endometriosis and Uterine Disorders (SEUD). It will evaluate the safety, tolerability, and pharmacokinetics of the IntraVag platform and drug candidates. During the study, the team will examine the promising potential of cannabinoids as they engage with the endocannabinoid system (ECS), which is extensively distributed in women's reproductive organs, such as the uterus and ovaries. This positioning makes the ECS a crucial target for addressing conditions like Endometriosis. In this context, cannabinoids may possess the capability to alleviate various types of Endometriosis-associated pain. Further, it can mitigate the inflammatory microenvironment associated with Endometriosis. Gynica's proprietary IntraVag technology enables controlled release and direct delivery of APIs to target organs. Gynica aims to pursue registration of its novel solutions with the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA). Pending positive Phase 1 results, the company plans to advance into Phase 2 efficacy trials rapidly. "After four years of rigorous pre-clinical research and development efforts, we are thrilled to announce this upcoming milestone during Endometriosis Awareness Month. This trial represents a significant step forward in our mission to revolutionise care and provide a better quality of life for the millions of women worldwide suffering from endometriosis. In this enormous unmet need, patients urgently seek efficient solutions," stated Yotam Hod, CEO of Gynica. "Endometriosis is now recognized as a chronic disease, and to have a non-hormonal treatment for Endometriosis-associated pain has an absolute priority for many patients who require long-term management and for the gynecologist in order to have new therapeutic options with multiple mechanisms of action, says Prof. Petraglia. SOURCE Gynica